Site Care Partner/Lead CRA - All US Locations - FSP

About the role

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Your priority is the safety and well-being of the patients. You travel to investigator sites and perform your monitoring duties, encouraging inquisitiveness, accountability, relationship-building, and integrity.

Key Accountabilities

• Site start-up and activation
• Supports processes to optimize country & site selection activities
• Qualifies and activates assigned sites
• Supports country-specific ICF review and deployment up to Site Activation
• Ensures site readiness for First Subject First Visit (FSFV)
• Builds and maintains relationships with Site Organizations and Strategic Partners
• Coordinates communications and resolution efforts for escalated site issues
• Ensures effective site recruitment planning and delivery
• Supports local Regulatory authorities and Study Start up teams
• Reviews Site Reports and related issues
• Supports the CRA to develop positive Investigator relationships

Skills

• Good clinical practice/ICH guidelines and other applicable regulatory requirements
• Good computer skills and willingness to embrace new technologies
• Strong communication, presentation, and interpersonal skills
• Ability to manage required travel
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage cross-functional relationships
• Able to communicate effectively and appropriately with internal & external stakeholders
• Adaptable to changing technologies and processes
• Knowledge of country requirements for GCP that may differ from client procedures
• Ability to overcome barriers encountered during process implementation
• Effective verbal and written communication skills

Experience

• Demonstrated experience in site management with prior experience as a CRA
• Experience in start-up activities through site activation
• Experience in conduct and close-out activities
• Knowledge of quality and regulatory requirements in applicable countries

Education

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)